Kornimate/medical-research-clean huggingface dataset:
et1 concentration, metabolic pathway activation, and pulmonary blood flow in infants undergoing superior cavo-pulmonary anastomosis

Conditions: Single-ventricle; Pulmonary Vascular Resistance Abnormality; Superior Cavo-Pulmonary Anastomosis; Endothelin; Metabolomics

Summary: this is a novel preliminary study of biomarkers of pathologic pre-operative pulmonary vascular development, elevated pre-operative pulmonary vascular resistance index (pvri), and complications associated with decreased post-operative pulmonary blood flow in single ventricle patients undergoing superior cavo-pulmonary anastomosis (scpa). the study will utilize a combined targeted and untargeted approach to both optimize translation of a promising existing biomarker and efficiently identify novel biomarkers and potential therapeutic targets in this population.

overall hypothesis: endothelin-1 (et1) and associated dysregulation of key metabolic pathways decrease pre-operative pulmonary blood vessel development and increase post-operative pulmonary blood vessel resistance leading to decreased pulmonary blood flow in patients undergoing scpa. for enrolled patients, collected data will include: * 3 ml blood sample (x2) at pre-scpa catheterization. * 3 ml blood samples at 2, 24, and 48 hours post-operative. * urine sample pre-operatively and post-operatively * collection of otherwise-discarded operative tissue sample from the pulmonary artery. * collection of clinical data, demographic data, and results of routine, post-operative hemodynamic monitoring.

Eligibility criteria:
inclusion criteria: * congenital heart disease patients undergoing catheterization for pre-spca evaluation or undergoing scpa without plans for cardiac catheterization (utilizing data from a previously performed clinical catheterization). * all patients will have age from 31 days to 2 years. exclusion criteria: * patients who will remain post-op with a pulsatile source of pulmonary blood flow in addition to the cavo-pulmonary anastomosis (so called "1.5 ventricle" repair) will be excluded. * due to limitations in acceptable sample blood volumes for research, patients with weight \<4kg will be excluded. * patients will not be excluded on the basis of gender, ethnicity, genetic diagnosis, gestational age at birth, non-cardiac comorbidity, or pre-operative medication regimen.
tigulixostat, phase 3 study, placebo controlled in gout patients

Conditions: Gout; Hyperuricemia; Gout Flare; Tophi

Summary: the aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of tigulixostat in gout patients with hyperuricemia.


Eligibility criteria:
inclusion criteria: * male or female subjects between the ages of 18 85 years, inclusive. * subjects with hyperuricemia and a history or presence of gout per american college of rheumatology/european league against rheumatism (acr/eular) 2015 criteria. * subjects who are currently on urate-lowering therapies (ult) with an sua level ≥6.0 mg/dl at screening (visit 1); or subjects who are currently not on ult with an sua level ≥7.0 mg/dl at screening (visit 1). subjects currently on ult will undergo washout and must have an sua level ≥7.0 mg/dl at visit 3 to be randomized and participate in the study. * subjects with a body mass index ≤50 kg/m2 and estimated glomerular filtration rate (egfr) ≥30 ml/min/1.73 m2 at screening (visit 1). exclusion criteria: * subjects with secondary hyperuricemia, enzymatic defects. * subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (visit 1). * subjects who have received pegloticase to treat gout which has not responded to the usual treatments. * subjects who have not been receiving stable doses of drugs known to affect sua levels for the last 3 weeks prior to screening (visit 1). * subjects with a history of xanthinuria (elevated levels of xanthine in the urine) and rheumatoid arthritis

Keywords: gout hyperuricemia xanthine oxidase inhibitor
the mechanism of tcf7l2 and slc30a8 on antipsychotic-induced metabolic syndrome

Conditions: Schizophrenia; Metabolic Syndrome

Summary: almost all of antipsychotics can induce metabolic syndrome,genetic factors play a key role in the development of metabolic syndrome,tcf7l2 and slc30a8 are strongestly correlated with metabolic syndrome.moreover,antipsychotics have an effect on the expression of tcf7l2 and slc30a8 genes.it indicates the variations of tcf7l2 and slc30a8 play an important part in the development of antipsychotics-induced metabolic syndrome.

* in this study, we will determine the effect of olanzapine on the expression of tcf7l2 and slc30a8. * the relationship of the polymorphism of tcf7l2 and slc30a8 with antipsychotic-induced metabolic syndrome in schizophrenia patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of first episode schizophrenia * must be able to swallow tablets * take only one antipsychotics exclusion criteria: * liver or renal or cardiovascular diseases * pregnant or lactating women * drug and alcohol dependence

Keywords: metabolic syndrome
conditioning regimen of bendamustine and melphalan followed by transplant in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the safety and efficacy of bendamustine (treanda™), in combination with melphalan in subjects with multiple myeloma who are undergoing an autologous stem cell transplant.

bendamustine (treanda™) has been used in clinical trials to treat multiple myeloma. the results from these trials suggest that it may be beneficial in the treatment of multiple myeloma in a different treatment context. researchers aim to determine if there may be an improved benefit in the context of bone marrow transplant. this initial clinical trial is intended to help determine how safe it is to use bendamustine as a conditioning regimen for bone marrow transplant, and to look for any initial evidence of benefit. bendamustine (treanda™) is approved by the food and drug administration (fda) for the treatment of chronic lymphocytic leukemia and melphalan is a type of chemotherapy drug. the use of melphalan alone as a conditioning regimen for autologous stem cell transplant is considered "standard of care," that is, the treatment or process that your doctor would normally follow to treat your disease. although bendamustine (treanda™) has been used in multiple myeloma research studies, the combination of bendamustine (treanda™) and melphalan as treatment for multiple myeloma is not approved by the fda, thus the combination therapy used in this research study is considered "investigational."

Eligibility criteria:
inclusion criteria: * patients with multiple myeloma who have received induction therapy and have had stem cells mobilized in preparation for autologous transplantation will be eligible for this study. patients are also eligible with relapsed or refractory disease, after attempts at more standard approaches, and with the availability of stem cells. * patients must be age 18 or older. * patients must have a life expectancy of at least 12 weeks. * patients must have an eastern cooperative oncology group (ecog) performance status of 0, 1 or 2. * patients must provide written informed consent. exclusion criteria: * impaired renal function with a measured or calculated creatinine clearance of less than 25 ml/min. * impaired hepatic function defined as a bilirubin greater than 1.5 x upper limit of normal (uln) or alanine aminotransferase (alt) or aspartate aminotransferase (ast) greater than 5 x uln. * serious active or uncontrolled infection or medical condition. * women who are pregnant or breast feeding. women of childbearing age must use adequate contraception and have a negative pregnancy test. * impaired pulmonary function with a diffusing capacity of the lung for carbon monoxide (dlco) less than 45% predicted. * impaired cardiac function with an ejection fraction less than 40% of predicted. * other systemic anticancer therapy or ongoing toxicities from such therapy.

Keywords: multiple myeloma autologous stem cell transplant asct mm
the role of pyroptosis in chronic venous disease

Conditions: Inflammation; Veins; Complication; Varicose Veins; Varicose Ulcer

Summary: enrollment criteria and clinical data collection: following the principles of medical ethics, the development of inclusion and exclusion criteria. selecting 200 cases of chronic venous disease (cvd) according to the comprehensive classification system for chronic venous disorders (ceap) divided into 6 clinical stages (c1-c6) (group a). selecting 200 healthy participants without cvd (c0) as controls (group b). blood samples will be collected from both groups. markers of pyroptosis (nets, caspase-1 and cytokines) will be evaluated between the two groups and between the subgroups, according to clinical stage, in group a.

pyroptosis is a pro-inflammatory form of regulated cell death and is dependent on networks of extracellular fibers (net,s), on the enzymatic activity of inflammatory proteases that belong to the family of cysteine-dependent aspartate-specific proteases (caspase), and cytokines. the role of inflammation has been previously demonstrated in chronic venous disease (cvd), which is a condition that affects up to 80% of adult population in western countries. according to the comprehensive classification system for chronic venous disorders (ceap) divided into 6 clinical stages: c0: no visible or palpable signs of venous disease. c1: telangiectasies or reticular veins. c2: varicose veins. c3: edema. c4a: pigmentation and eczema. c4b: lipodermatosclerosis and atrophie blanche. c5: healed venous ulcer. c6: active venous ulcer. the aim of this study is to evaluate the role of pyroptosis in the onset and progression of cvd. the investigators will select 200 participants with chronic venous disease (cvd) according to clinical stage of ceap (c1-c6 patients) \[group a\] . the investigators will also select 200 healthy participants without cvd (c0) as controls \[group b\]. peripheral vein blood samples will be collected from both groups. markers of pyroptosis (nets, caspase-1 and cytokines) will be evaluated between the two groups and between the subgroups of group a, according to clinical stage.

Eligibility criteria:
inclusion criteria: * chronic venous disease (c1-c6 ceap classification ) exclusion criteria: * peripheral artery disease * malignant tumors * severe cardiovascular and cerebrovascular disease * liver and kidney failure

Keywords: chronic vein disease inflammation pyroptosis
precision medicine for the prediction of treatment (prompt) response (prompt)

Conditions: Major Depressive Disorder

Summary: major depressive disorder (mdd) is the most common psychiatric disease worldwide with a huge socio-economic impact. pharmacotherapy represents the first-line treatment choice; however, only about one third of patients respond to the first trial and about 30% are classified as treatment-resistant depression (trd). trd is associated with specific clinical features and genetic/gene expression signatures. to date, single sets of markers have shown limited power in response prediction. the aim of this project is the development of a precision medicine algorithm that would help early detection of non-responder patients, who might be more prone to later develop trd. in this phase of the project a naturalistic cohort of 300 mdd patients will be recruited. the data collected will be used to assess, in real-world conditions, the capability of an innovative algorithm (integrating clinical, omics and gender data of other 300 patients con mdd) to predict the treatment outcomes. this project represents a proof-of-concept study. the obtained results will provide information about the feasibility and usefulness of the proposed approach, with the perspective of designing future clinical trials in which algorithms could be tested as a predictive tool to drive decision making by clinicians, enabling a better prevention and management of mdd resistance.


Eligibility criteria:
inclusion criteria: * a current diagnosis of moderate to severe mdd according to the dsm-iv was confirmed using the scid-i diagnostic scale exclusion criteria: * mental retardation or cognitive disorder * a lifetime history of schizophrenic, schizoaffective, or bipolar disorder substance abuse in the last 3 months * personality disorders, substance abuse, alcohol abuse, obsessive compulsive disorder, post-traumatic stress disorder, as primary diagnosis * comorbidity with eating disorders * substance or alcohol dependence
monocytes in subjects with type 1 diabetes and chronic kidney disease

Conditions: Chronic Kidney Disease(CKD); Type 1 Diabetes (T1D)

Summary: this is a cross-sectional study in patients with type 1 diabetes (tid) and chronic kidney disease (ckd) to test if time in range (tir) affects the degree of hyperglycemia required for monocyte activation, podocyte injury, and assess if monocyte activation is attenuated by glucagon-like peptide (glp-1) agonist treatment ex vivo.

the monocyte response from patients with t1d ckd will be compared to monocytes from t1d subjects without ckd as a control. potential subjects will be recruited from existing cleveland clinic patients or the community. the study will entail an initial phone screen followed by a formal screening visit to determine eligibility. eligible subjects will return for a study visit within 4 weeks for a blood draw. there is no intervention. this will complete the study for subjects unless the investigators do not obtain enough monocytes from the initial blood draw to complete the requisite lab studies. if this occurs, the investigators will ask the patient to return for a repeat study visit. all endpoints evaluating monocyte and podocyte injury will be conducted in the lab ex vivo.

Eligibility criteria:
inclusion criteria: 1. t1d ckd subjects: 1. adults, males or females diagnosed with t1d 2. age 18-65 years 3. diagnosed with ckd (egfr 60-90 ml/min/1.73 m2) 4. diagnosed with albuminuria (uacr 30-500 mg/g) 5. on insulin injections or pump 6. on cgm based on baseline cgm metrics, the investigators will stratify subjects to 2 groups group a (lower tir group): tir\ 70% a1c 5.0-7.0 2. controls: t1d subjects without ckd 1. adults, males or females diagnosed with t1d 2. age 18-65 years 3. no ckd (egfr \>90 ml/min/1.73 m2) 4. no albuminuria (uacr \<30 mg/g) 5. on insulin injections or pump 6. on cgm based on baseline cgm metrics, the investigators will stratify subjects to 2 groups group a (lower tir group): tir\ 70% a1c 5.0-7.0 exclusion criteria: 1. hemoglobin \<9 2. on glp-1 agonist or dpp4 inhibitor or sodium-glucose co-transporter-2 inhibitors use within 30 days 3. pregnancy or plans to become pregnant 4. on steroids 5. diagnosed with cancer, immunosuppression/autoimmune conditions 6. reported heavy alcohol use or recreational drug use 7. any condition which jeopardizes patient safety or affects monocytes at physician's discretion
transcranial direct current stimulation aided rehabilitation of gait in subacute stroke

Conditions: Stroke; Neurorehabilitation

Summary: the purpose of this study is to determine if transcranial direct current stimulation (tdcs)applied over the lower extremity motor cortex in conjunction with treadmill training is effective for improving gait in patients with subacute stroke and to evaluate the effect and predictive value of a single session of anodal tdcs.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * onset of stroke less than 14 days * first ischemic stroke causing lower limb weakness (mrc score ≤4 in knee extensors) and gait impairment exclusion criteria: * contraindications to mri or tms * other neurological disorders * significant somatic or psychiatric disorders * history of seizures * language or cognitive disorders prohibiting participation
safety and effectiveness of the external fastening system for temporary active fixation pacemakers (tempace)

Conditions: Arrythmia; Bradycardia

Summary: temporary cardiac pacing with active-fixation leads (tpafl) using a reusable permanent pacemaker generator has been shown to be safer than lead systems without fixation. however, tpafl requires the off-label (non-certificated) use of pacemaker leads and generators. it is designed a fastening system to ensure the safety and efficacy of the procedure: the kronosafe system®. the aim of this study is to demonstrate the safety and effectiveness of the kronosafe system® for temporary pacing in a series of patients receiving tpafl.


Eligibility criteria:
inclusion criteria: * patient older than 18 years. * need for temporary cardiac stimulation * temporary active fixation pacemaker implantation through left or right jugular access. * signature of informed consent * correct functioning of the electrode after the implantation: sensing of the r wave above 5 millivolts. ventricular pacing threshold below 1 volt. electrode impedance between 400-1200 ohm. * pacemaker programming with stimulation output at 5 volts intensity and 1 millisecond pulse duration. * placement of the kronosafe® fastening system after electrode implantation. exclusion criteria: * complication during the procedure: pneumothorax, hematoma at the puncture site, cardiac perforation, accidental arterial puncture or other that, in the investigator's opinion, poses an added risk of pacemaker dysfunction. * need to transfer the patient to another center with loss of follow-up. * absence of surveillance through continuous electrocardiographic monitoring with detection of arrhythmic events.

Keywords: pacemaker cardiac pacing bradycardia arrhythmia treatment outcome
the effect of reiki on symptom control and quality of life in breast cancer patients

Conditions: Breast Cancer; Symptoms and Signs; Quality of Life

Summary: the aim of this study is to examine the effect of reiki on symptom control and quality of life in breast cancer patients.

breast cancer is the world's second most common type of cancer, the most frequently diagnosed cancer in women, and the leading cause of cancer death. energy therapies have an essential place in complementary and alternative treatments that are commonly used in breast cancer patients. reiki, practiced by trained practitioners, is performed by activating the body's energy centers, including blood and lymph circulation, and stimulating the nervous system, thus providing energy circulation and providing mental-physical relaxation, positively affecting health. the effect of reiki on cancer patients has been shown in studies that it can relieve pain, reduce anxiety and depression, improve quality of life and reduce fatigue. in this study, women with stage 3 and 4 metastatic breast cancer who were diagnosed with breast cancer for at least 3 months and received at least two cycles of chemotherapy in the outpatient chemotherapy unit of the medical oncology outpatient clinic of a training and research hospital will be included. it is aimed to reach a total of 52 women who meet the inclusion criteria and agreed to participate in the study between february 1, 2023, and july 30, 2023. patient descriptive information form, edmonton symptom diagnosis scale (esto), and european association for cancer research and treatment br23 quality of life scale (eortc-qlq-br232) preliminary tests will be applied to all women. patients will be randomized 1:1 into groups by a single therapist according to the block randomization method. under the guidance of a researcher holding a usui reiki master \& teacher degree, a total of 26 patients in the intervention group will be given a short 30-minute application to energy centers by researchers with a second-degree reiki practitioner. on the second and on third days, 30 minutes of short reiki will be done remotely. no treatment will be applied to 26 patients in the control group. post-tests will be applied to all patients 3 days and 10 days after they were included in the study.

Eligibility criteria:
inclusion criteria: * women with at least 3 months of breast cancer diagnosis, at least two cycles of chemotherapy, and stage 3 and 4 metastatic breast cancer. exclusion criteria: * those who have difficulty in responding to the data collection form to be used in the research and have problems in understanding and communicating turkish, * those who refuse to answer the reiki application and data collection tools, * those who want to leave the research while the research is continuing, * those who received any supplementary application in the last 6 months will be excluded from the study.

Keywords: reiki breast cancer symptom control quality of life
the role of family integrated care in maternal empowerment

Conditions: Family; Premature; Empowerment

Summary: family integrated care is designed to eliminate the barriers between parents and their infants in the nicu by involving parents of premature infants in their care. parents are integrated into both the healthcare team and the care of their infant. through this approach, parents are informed about how they can contribute to their infant's overall development, including neurological and sensory development, motor and behavioral progress, as well as practices such as touch, bonding, skin-to-skin contact, breastfeeding, and increasing breast milk production. they are also educated on general hygiene and care tasks such as diaper changing and body cleaning. this model places importance on the protection and enhancement of both the physical and psychological well-being of the parent and the infant. during this process, parents move beyond being mere "visitors" in the unit to becoming active "participants" and members of the care team. family integrated care aims to support parents in becoming the primary caregivers for their infants, both during hospitalization and after discharge. this model not only provides education and counseling but also supports the family's comprehensive involvement in the infant's care.


Eligibility criteria:
inclusion criteria: * the newborn must be premature (gestational age \>28 and \<34 weeks), * the infant must be admitted to the nicu and hospitalized for at least 3 days, * the mother must be open to communication and cooperation, * the mother must voluntarily agree to participate in the study, * the mother must be literate, * the mother must be able to speak and understand turkish, * the mother must be primiparous and experiencing motherhood for the first time, * the mother must be over 18 years of age, * mothers in the intervention group must be present in the hospital for an average of 6-8 hours per day. exclusion criteria: * the newborn has a congenital anomaly (e.g., craniofacial anomalies such as cleft palate, cleft lip, or facial muscle paralysis), * the newborn has a diagnosed gastrointestinal, neurological, or genetic disorder (e.g., necrotizing enterocolitis, hydrocephalus, down syndrome, omphalocele, gastroschisis, short bowel syndrome, or other diseases), * the newborn has a congenital heart defect requiring surgical intervention, * the mother has a diagnosed psychiatric illness, * the mother and/or father do not wish to participate in the study. withdrawal criteria: * the mother does not attend the training sessions during the study period, * the mother fails to maintain cooperation throughout the study, * the newborn is transferred to another healthcare center for any reason, * the mother wishes to withdraw from the study, * the newborn is diagnosed with a chronic illness during the study process.

Keywords: empowerment neonatal premature family nursing